OVM-200 Drug Product, manufactured to Good Manufacturing Process (GMP), has been certified stable two years post manufacture – a major milestone for OVM’s lead cancer vaccine development
Oxford, UK – 12th May 2023
Oxford Vacmedix (OVM), the UK-based biopharma company developing therapeutic cancer vaccines, announced today that OVM-200 which was manufactured on contract by Eurofins Amatsi to exacting GMP standards, has been tested and certified as stable two years after manufacture. The GMP drug substance for OVM-200 is dispensed into vials for use in clinical trials and is being used in the ongoing Phase 1 trial of OVM-200. Two year stability is an important milestone in the development of cost efficient cancer vaccines using the novel Recombinant Overlapping Peptide (ROP) technology pioneered by Professor Shisong Jiang.
OVM-200 is an ROP based vaccine that targets survivin, over expressed in many solid tumours. It is being trialled in the UK in five leading hospitals, to treat ovarian cancer, prostate cancer and non-small cell lung cancer. Phase 1a, the first part of a Phase 1 trial, has been completed and has demonstrated both safety and a strong immune response as well as allowing the selection of the optimal dose of OVM-200 for use to treat late stage cancer.
Dr Debra Nevin, CEO and Senior Consultant at Amethyst Pharma commented;
“The Recombinant Overlapping Peptide platform technology is a completely new approach for making vaccines to treat cancer. Manufacturing these complex peptides is not straightforward and new techniques had to be developed to manufacture the first ROP vaccine, OVM-200, to GMP standard. The robustness of the manufacturing process is demonstrated drug product for OVM-200 remaining stable at two years.”
William Finch, CEO of Oxford Vacmedix added;
“We are very pleased to have reached this significant milestone for OVM-200. Stable drug product means that existing stock can be used for continuing progress with OVM-200 and that future manufacturing of ROP based vaccines is likely to have at least three-year stability. This will contribute towards cost efficient manufacturing and lower cost of goods. With ongoing testing, we plan to extend the stability profile of our ROP vaccines.”
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William Finch, CEO, Oxford Vacmedix
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Dr Anthony Coombs, Executive Chairman, Oxford Vacmedix
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Notes to Editor
About Oxford Vacmedix
Oxford Vacmedix UK Ltd, based at the Oxford Science Park, UK, is a bio-pharma company that was spun out from the University of Oxford’s Department of Oncology and is utilising the novel proprietary platform technology of recombinant overlapping peptides (ROPs) invented by Professor Shisong Jiang. ROPs have been validated as a technology to stimulate broad and strong T cell immunity therefore forming a good platform for therapeutic vaccines and diagnostics in cancer and infectious diseases.
The technology uses the novel, proprietary platform of ROPs to design and develop therapeutic cancer vaccines and diagnostics with the potential for increased efficacy, lower costs, simpler regulatory pathways and synergy when used in combination with other immune oncology (IO) agents. The company has extensive contacts and collaborations in China through Changzhou Bioscience Group (CBIG) that is using the ROP platform for diagnostics in both cancer and in infectious diseases.
OVM is developing two lead vaccines, OVM-100 and OVM-200, focusing on unmet clinical need. OVM-100 is an HPV vaccine targeted at cervical cancer, and OVM-200 represents a new type of vaccine utilising survivin to target solid tumours including prostate, ovarian and non-small cell lung cancer (NSCLC). Both vaccines will be tested as single agents and in combination with IO agents. OVM has a strong pipeline, with a diagnostic for anti-microbial resistance being tested and two other cancer vaccines is preclinical development.
OVM secured Series A investment from Dx&Vx (formerly Cancer ROP), a leading South Korean biotech company, and from existing shareholders in China in 2018. The company is currently seeking Series B funding to advance OVM-200 to Phase 2 and OVM-100 into Phase 1 trials, as monotherapy and also in combination. In addition, the option of using MRNA delivery with the ROP technology will be explored.
For more information: https://www.oxfordvacmedix.com